Devices and systems for providing neurostimulation to a target location, may include an implantable neurostimulator device including a first transducer device that includes a gas matrix piezoelectric (GMP) array or a piezoelectric micromachined ultra-sound transducer (pMUT) array; the implantable neurostimulator device has a length of 5 mm to 20 mm and a diameter of 1 mm to 5 mm and an energy delivery device including a second transducer device; the second transducer device includes a gas matrix piezoelectric (GMP) array, a polymer matrix piezocomposite array, a capacitive micro-machined acoustic transducer (cMUT) array, or a pMUT ar-2024/097917 ray; and a beam-forming processor to cause the second transducer device to produce an acoustic wave, the implantable neurostimulator device is to receive the acoustic wave from the energy delivery device, convert the acoustic wave to an electrical energy signal, and apply the electrical energy signal.
Legal claims defining the scope of protection, as filed with the USPTO.
a gas matrix piezoelectric (GMP) array; or a piezoelectric micromachined ultrasound transducer (pMUT) array; at least one transducer device comprising: lead zirconate titanate (PZT); single crystal lead magnesium niobate-lead titanate (PMN-PT); aluminum nitride (AlN); scandium (Sc) doped AlN; or any combination thereof; wherein the at least one transducer device comprises a material, and wherein the material comprises: wherein the implantable neurostimulator device has a length in a range of 5 mm to mm and a diameter in a range of 1 mm to 5 mm. . An implantable neurostimulator device comprising:
claim 1 PZT; polyvinylidene fluoride; polyvinylidene difluoride (PVDF); or any combination thereof. . The implantable neurostimulator device of, wherein the at least one transducer device comprises a plurality of transducer elements, and wherein each transducer element of the plurality of transducer elements comprises:
claim 2 . The implantable neurostimulator device of, wherein the plurality of transducer elements are formed in a plurality of rows, and wherein the plurality of rows are spaced equidistant around a perimeter of the at least one transducer device.
claim 1 PZT; and AlN. . The implantable neurostimulator device of, wherein the at least one transducer device comprises the pMUT array, and wherein the pMUT array comprises:
claim 1 . The implantable neurostimulator device of, wherein the at least one transducer device is operated independent of an onboard processor.
claim 1 an enclosure, wherein the enclosure has a cylindrical design with a plurality of internal surfaces; and wherein the at least one transducer device comprises a plurality of elements of the pMUT array that are positioned on the plurality of internal surfaces of the enclosure. . The implantable neurostimulator device of, further comprising:
claim 6 . The implantable neurostimulator device of, wherein the plurality of elements of the pMUT array comprises a plurality of thin film elements deposited on the plurality of internal surfaces of the enclosure.
claim 1 receive an acoustic signal from an energy delivery device; and convert the acoustic signal to an electrical signal to provide an action potential to activate a nerve. . The implantable neurostimulator device of, wherein the at least one transducer device is configured to:
claim 8 an electrode device, wherein the electrode device is configured to receive the electrical signal and apply the electrical signal to an environment inside a body of a patient. . The implantable neurostimulator device of, further comprising:
claim 1 a rectification circuit, wherein the rectification circuit is configured to covert an output of the at least one transducer to a direct current (DC) electrical pulse to provide electrical stimulation to an environment inside a body of a patient. . The implantable neurostimulator device of, further comprising:
claim 1 a core structure, wherein the core structure is sized and configured to hold the plurality of transducer elements. . The implantable neurostimulator device of, wherein the at least one transducer device comprises a plurality of transducer elements, and the implantable neurostimulator device further comprises:
a gas matrix piezoelectric (GMP) array; or a piezoelectric micromachined ultrasound transducer (pMUT) array; at least one first transducer device comprising: lead zirconate titanate (PZT); single crystal lead magnesium niobate-lead titanate (PMN-PT); aluminum nitride (AlN); scandium (Sc) doped AlN; or any combination thereof; wherein the at least one first transducer device comprises a material, and wherein the material comprises: wherein the implantable neurostimulator device has a length in a range of 5 mm to 20 mm and a diameter in a range of 1 mm to 5 mm; an implantable neurostimulator device comprising: lead zirconate titanate (PZT); polyvinylidene difluoride (PVDF); aluminum nitride (AlN); scandium (Sc) doped AlN; or any combination thereof; at least one second transducer device, wherein the at least one second transducer device comprises a material, and wherein the material comprises: a gas matrix piezoelectric (GMP) array; a polymer matrix piezocomposite array; a capacitive micro-machined acoustic transducer (cMUT) array; or a piezoelectric micromachined ultrasound transducer (pMUT) array; and wherein the at least one second transducer device comprises: cause the at least one second transducer device to produce an acoustic wave; at least one beam-forming processor configured to: an energy delivery device comprising: receive the acoustic wave from the energy delivery device; covert the acoustic wave to an electrical energy signal; and wherein the implantable neurostimulator device is configured to: apply the electrical energy signal to an environment inside a body of a patient. . A system for providing neurostimulation to a target location of a body of a user, comprising:
claim 12 . The system of, wherein the acoustic wave comprises a plurality of pulses having a pulse repetition frequency, wherein a pulse width of each pulse of the plurality of pulses is in a range of 10 ns to 10 μs, and wherein the pulse repetition frequency is in a range of 1 Hz to 50 Hz.
claim 12 PZT; polyvinylidene fluoride; PVDF; or any combination thereof. . The system of, wherein the at least one first transducer device comprises a plurality of transducer elements, and wherein each transducer element of the plurality of transducer elements comprises:
claim 12 . The system of, wherein the plurality of transducer elements are formed in a plurality of rows, and wherein the plurality of rows are spaced equidistant around a perimeter of the at least one first transducer device.
claim 12 PZT; and AlN. . The system of, wherein the at least one first transducer device comprises the pMUT array, and wherein the pMUT array comprises:
claim 12 . The system of, wherein the at least one first transducer device is operated independent of an onboard processor.
claim 12 an enclosure, wherein the enclosure has a cylindrical design with a plurality of internal surfaces; and wherein the at least one first transducer device comprises a plurality of elements of the pMUT array that are positioned on the plurality of internal surfaces of the enclosure. . The system of, further comprising:
claim 18 . The system of, wherein the plurality of elements of the pMUT array comprises a plurality of thin film elements deposited on the plurality of internal surfaces of the enclosure.
claim 12 receive an acoustic signal from an energy delivery device; and convert the acoustic signal to an electrical signal to provide an action potential to activate a nerve. . The system of, wherein the at least one first transducer device is configured to:
claim 20 an electrode device, wherein the electrode device is configured to receive the electrical signal and apply the electrical signal to an environment inside a body of a patient. . The system of, further comprising:
claim 12 a rectification circuit, wherein the rectification circuit is configured to covert an output of the at least one first transducer to a direct current (DC) electrical pulse to provide electrical stimulation to an environment inside a body of a patient. . The system of, further comprising:
claim 12 a core structure, wherein the core structure is sized and configured to hold the plurality of transducer elements. . The system of, wherein the at least one first transducer device comprises a plurality of transducer elements, and the implantable neurostimulator device further comprises:
35 -. (canceled)
Complete technical specification and implementation details from the patent document.
This application claims priority to United States Provisional Ser. No. 63/422,478 , filed Nov. 4, 2022, the disclosure of which is hereby incorporated by reference in its entirety.
The present disclosure relates to implantable medical devices and use of the same for treating patients. More particularly, the present disclosure relates to implantable neurostimulator devices and use of the same for treating various ailments and conditions in patients.
An implantable medical device may refer to an instrument that is either wholly or partially introduced into a body of a patient during a medical procedure. In some instances, physicians implant the implantable medical device during a surgical procedure. However, unlike surgical medical devices, implantable medical devices stay in the body after the medical procedure. In addition, externally powered and/or controlled implantable medical devices may allow for increased comfort and reduced risk of further complications (e.g., infection) for patients as treatments and are provided via the implantable medical devices.
However, providing power and/or control signals may be difficult based on a composition of the body of the patient. For example, providing power and/or control signals to an implantable medical device may be difficult if the implantable medical device is positioned deep inside the body of the patient. Further, parameters for operating an implantable medical device may be limited based on characteristics of the size, construction materials, and/or desired positions in the body of the implantable medical device.
Accordingly, disclosed are devices, systems, methods, and products for providing a treatment to a target location, such as an electrical stimulation to a nerve and/or a neuron, using an implantable neurostimulator device.
Further embodiments or aspects are set forth in the following numbered clauses:
Clause 1: An implantable neurostimulator device comprising: at least one transducer device comprising: a gas matrix piezoelectric (GMP) array; or a piezoelectric micromachined ultrasound transducer (pMUT) array; wherein the at least one transducer device comprises a material, and wherein the material comprises: lead zirconate titanate (PZT); single crystal lead magnesium niobate-lead titanate (PMN-PT); aluminum nitride (AlN); scandium (Sc) doped AlN; or any combination thereof; wherein the implantable neurostimulator device has a length in a range of 5 mm to 20 mm and a diameter in a range of 1 mm to 5 mm.
Clause 2: The implantable neurostimulator device of clause 1, wherein the at least one transducer device comprises a plurality of transducer elements, and wherein each transducer element of the plurality of transducer elements comprises: PZT; polyvinylidene fluoride; polyvinylidene difluoride (PVDF); or any combination thereof.
Clause 3: The implantable neurostimulator device of any of clause 1 or clause 2, wherein the plurality of transducer elements are formed in a plurality of rows, and wherein the plurality of rows are spaced equidistant around a perimeter of the at least one transducer device.
Clause 4: The implantable neurostimulator device of any of clauses 1-3, wherein the at least one transducer device comprises the pMUT array, and wherein the pMUT array comprises: PZT; and AlN.
Clause 5: The implantable neurostimulator device of any of clauses 1-4, wherein the at least one transducer device is operated independent of an onboard processor.
Clause 6: The implantable neurostimulator device of any of clauses 1-5, further comprising: an enclosure, wherein the enclosure has a cylindrical design with a plurality of internal surfaces; and wherein the at least one transducer device comprises a plurality of elements of the pMUT array that are positioned on the plurality of internal surfaces of the enclosure.
Clause 7: The implantable neurostimulator device of any of clauses 1-6, wherein the plurality of elements of the pMUT array comprises a plurality of thin film elements deposited on the plurality of internal surfaces of the enclosure.
Clause 8: The implantable neurostimulator device of any of clauses 1-7, wherein the at least one transducer device is configured to: receive an acoustic signal from an energy delivery device; and convert the acoustic signal to an electrical signal to provide an action potential to activate a nerve.
Clause 9: The implantable neurostimulator device of any of clauses 1-8, further comprising: an electrode device, wherein the electrode device is configured to receive the electrical signal and apply the electrical signal to an environment inside a body of a patient.
Clause 10: The implantable neurostimulator device of any of clauses 1-9, further comprising: a rectification circuit, wherein the rectification circuit is configured to covert an output of the at least one transducer to a direct current (DC) electrical pulse to provide electrical stimulation to an environment inside a body of a patient.
Clause11: The implantable neurostimulator device of any of clauses 1-10, wherein the at least one transducer device comprises a plurality of transducer elements, and the implantable neurostimulator device further comprises: a core structure, wherein the core structure is sized and configured to hold the plurality of transducer elements.
Clause 12: A system for providing neurostimulation to a target location of a body of a user, comprising: an implantable neurostimulator device comprising: at least one first transducer device comprising: a gas matrix piezoelectric (GMP) array; or a piezoelectric micromachined ultrasound transducer (pMUT) array; wherein the at least one first transducer device comprises a material, and wherein the material comprises: lead zirconate titanate (PZT); single crystal lead magnesium niobate-lead titanate (PMN-PT); aluminum nitride (AlN); scandium (Sc) doped AlN; or any combination thereof; wherein the implantable neurostimulator device has a length in a range of 5 mm to 20 mm and a diameter in a range of 1 mm to 5 mm; an energy delivery device comprising: at least one second transducer device, wherein the at least one second transducer device comprises a material, and wherein the material comprises: lead zirconate titanate (PZT); polyvinylidene difluoride (PVDF); aluminum nitride (AlN); scandium (Sc) doped AlN; or any combination thereof; wherein the at least one second transducer device comprises: a gas matrix piezoelectric (GMP) array; a polymer matrix piezocomposite array; a capacitive micro-machined acoustic transducer (cMUT) array; or a piezoelectric micromachined ultrasound transducer (pMUT) array; and at least one beam-forming processor configured to: cause the at least one second transducer device to produce an acoustic wave; wherein the implantable neurostimulator device is configured to: receive the acoustic wave from the energy delivery device; covert the acoustic wave to an electrical energy signal; and apply the electrical energy signal to an environment inside a body of a patient.
Clause 13: The system of clause 12, wherein the acoustic wave comprises a plurality of pulses having a pulse repetition frequency, wherein a pulse width of each pulse of the plurality of pulses is in a range of 10 ns to 10 μs, and wherein the pulse repetition frequency is in a range of 1 Hz to 50 Hz.
Clause 14: The system of clause 12 or clause 13, wherein the at least one first transducer device comprises a plurality of transducer elements, and wherein each transducer element of the plurality of transducer elements comprises: PZT; polyvinylidene fluoride; PVDF; or any combination thereof.
Clause 15: The system of any of clauses 12-14, wherein the plurality of transducer elements are formed in a plurality of rows, and wherein the plurality of rows are spaced equidistant around a perimeter of the at least one first transducer device.
Clause 16: The system of any of clauses 12-15, wherein the at least one first transducer device comprises the pMUT array, and wherein the pMUT array comprises: PZT; and AlN.
Clause 17: The system of any of clauses 12-16, wherein the at least one first transducer device is operated independent of an onboard processor.
Clause 18: The system of any of clauses 12-17, further comprising: an enclosure, wherein the enclosure has a cylindrical design with a plurality of internal surfaces; and wherein the at least one first transducer device comprises a plurality of elements of the pMUT array that are positioned on the plurality of internal surfaces of the enclosure.
Clause 19: The system of any of clauses 12-18, wherein the plurality of elements of the pMUT array comprises a plurality of thin film elements deposited on the plurality of internal surfaces of the enclosure.
Clause 20: The system of any of clauses 12-19, wherein the at least one first transducer device is configured to: receive an acoustic signal from an energy delivery device; and convert the acoustic signal to an electrical signal to provide an action potential to activate a nerve.
Clause 21: The system of any of clauses 12-20, further comprising: an electrode device, wherein the electrode device is configured to receive the electrical signal and apply the electrical signal to an environment inside a body of a patient.
Clause 22: The system of any of clauses 12-21, further comprising: a rectification circuit, wherein the rectification circuit is configured to covert an output of the at least one first transducer to a direct current (DC) electrical pulse to provide electrical stimulation to an environment inside a body of a patient.
Clause 23: The system of any of clauses 12-22, wherein the at least one first transducer device comprises a plurality of transducer elements, and the implantable neurostimulator device further comprises: a core structure, wherein the core structure is sized and configured to hold the plurality of transducer elements.
Clause 24: A method of treating pain in a patient, comprising: stimulating a nerve or neuron in the patient with an implantable neurostimulator device, wherein implantable neurostimulator device comprises: at least one transducer device, wherein the at least one transducer device comprises a material, and wherein the material comprises: lead zirconate titanate (PZT); single crystal lead magnesium niobate-lead titanate (PMN-PT); aluminum nitride (AlN); scandium (Sc) doped AlN; or any combination thereof; wherein the at least one transducer device comprises: a gas matrix piezoelectric (GMP) array; or a piezoelectric micromachined ultrasound transducer (pMUT) array; wherein the implantable neurostimulator device has a length in a range of 5 mm to 20 mm and a diameter in a range of 1 mm to 5 mm; and wherein the nerve or neuron is one or more of supratrochlear, auriculotemporal, orbital, vagus, trigeminal, dorsal root ganglion, and/or sphenopalatine ganglion nerve or neuron; thereby treating the pain in the patient.
Clause 25: The method of clause 24, wherein stimulating the nerve or neuron with an implantable neurostimulator device, comprises: stimulating one or more branches of the trigeminal nerve, wherein the one or more branches of the trigeminal nerve comprises ophthalmic, maxillary, mandibular, supraorbital, infraorbital, occipital, and/or auriculotemporal branches of the trigeminal nerve.
Clause 26: The method of clause 24 or clause 25, wherein the pain comprises a migraine headache or a cluster headache.
Clause 27: The method of any of clauses 24-26, wherein the pain comprises craniofacial pain.
Clause 28: The method of any of clauses 24-27, wherein the pain comprises head and/or neck pain.
Clause 29: The method of any of clauses 24-28, wherein the pain comprises regional pain, wherein the reginal pain comprises chronic regional pain syndrome.
Clause 30: A method of treating a condition associated with inflammation and/or immunoregulation in a patient, comprising: stimulating a nerve or a neuron in the patient with an implantable neurostimulator device, wherein the implantable neurostimulator device comprises: at least one transducer device, wherein the at least one transducer device comprises a material, and wherein the material comprises: lead zirconate titanate (PZT); single crystal lead magnesium niobate-lead titanate (PMN-PT); aluminum nitride (AlN); scandium (Sc) doped AlN; or any combination thereof; wherein the at least one transducer device comprises: a gas matrix piezoelectric (GMP) array; or a piezoelectric micromachined ultrasound transducer (pMUT) array; wherein the implantable neurostimulator device has a length in a range of 5 mm to 20 mm and a diameter in a range of 1 mm to 5 mm; and wherein the nerve or the neuron is a splenic nerve or neuron; thereby treating the condition associated with inflammation and/or immunoregulation in the patient.
Clause 31: The method of clause 30, wherein the condition associated with inflammation and/or immunoregulation comprises: inflammatory arthritis, inflammatory bowel disease, multiple sclerosis, post-surgical inflammation, and/or post-ischemic inflammation.
Clause 32: The method of clause 30 or clause 31, wherein the condition associated with inflammation and/or immunoregulation comprises rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and/or lupus.
Clause 33: A method of treating hypertension in a patient, comprising: stimulating an artery in the patient with an implantable neurostimulator device, wherein the implantable neurostimulator device comprises: at least one transducer device, wherein the at least one transducer device comprises a material, and wherein the material comprises: lead zirconate titanate (PZT); single crystal lead magnesium niobate-lead titanate (PMN-PT); aluminum nitride (AlN); scandium (Sc) doped AlN; or any combination thereof; wherein the at least one transducer device comprises: a gas matrix piezoelectric (GMP) array; or a piezoelectric micromachined ultrasound transducer (pMUT) array; and wherein the implantable neurostimulator device has a length in a range of 5 mm to 20 mm and a diameter in a range of 1 mm to 5 mm; thereby treating hypertension in the patient.
Clause 34: The method of clause 33, wherein stimulating the artery in the patient with the implantable neurostimulator device comprises: stimulating a renal artery in the patient with the implantable neurostimulator device.
Clause 35: A method of treating a condition associated with overactive bladder and/or pelvic floor dysfunction in a patient, comprising: stimulating a nerve or a neuron in the patient with an implantable neurostimulator device, wherein the implantable neurostimulator device comprises: at least one transducer device, wherein the at least one transducer device comprises a material, and wherein the material comprises: lead zirconate titanate (PZT); single crystal lead magnesium niobate-lead titanate (PMN-PT); aluminum nitride (AlN); scandium (Sc) doped AlN; or any combination thereof; wherein the at least one transducer device comprises: a gas matrix piezoelectric (GMP) array; or a piezoelectric micromachined ultrasound transducer (pMUT) array; wherein the implantable neurostimulator device has a length in a range of 5 mm to 20 mm and a diameter between 1 mm to 5 mm; and wherein the nerve or neuron is a tibial and/or sacral nerve or neuron; and thereby treating the condition associated with overactive bladder and/or pelvic floor dysfunction in the patient in the patient.
These and other features and characteristics of the presently disclosed subject matter, as well as the methods of operation and functions of the related elements of structures and the combination of parts and economies of manufacture, will become more apparent upon consideration of the following description and the appended claims, all of which form a part of this specification, wherein like reference numerals designate corresponding parts in the various figures. It is to be expressly understood, however, that the drawings are for the purpose of illustration and description only and are not intended as a definition of the limits of the disclosed subject matter. As used in the specification and the claims, the singular form of “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.
For purposes of the description hereinafter, the terms “end,” “upper,” “lower,” “right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,” “longitudinal,” and derivatives thereof shall relate to the disclosure as it is oriented in the drawing figures. However, it is to be understood that the disclosure may assume various alternative variations and step sequences, except where expressly specified to the contrary. It is also to be understood that the specific devices and processes illustrated in the attached drawings, and described in the following specification, are simply exemplary embodiments or aspects of the disclosure. Hence, specific dimensions and other physical characteristics related to the embodiments or aspects of the embodiments disclosed herein are not to be considered as limiting unless otherwise indicated.
No aspect, component, element, structure, act, step, function, instruction, and/or the like used herein should be construed as critical or essential unless explicitly described as such. In addition, as used herein, the articles “a” and “an” are intended to include one or more items and may be used interchangeably with “one or more” and “at least one.” Furthermore, as used herein, the term “set” is intended to include one or more items (e.g., related items, unrelated items, a combination of related and unrelated items, etc.) and may be used interchangeably with “one or more” or “at least one.” Where only one item is intended, the term “one” or similar language is used. Also, as used herein, the terms “has,” “have,” “having,” or the like are intended to be open-ended terms. Further, the phrase “based on” is intended to mean “based at least partially on” unless explicitly stated otherwise. The phrase “based on” may also mean “in response to” where appropriate and may refer to a condition for automatically triggering a specified operation of an electronic device (e.g., a computing device or the like).
Embodiments of the present disclosure may include an implantable neurostimulator device comprising at least one transducer device that includes a gas matrix piezoelectric (GMP) array, or a piezoelectric micromachined ultrasound transducer (pMUT) array, wherein the at least one transducer device comprises a material, wherein the material includes lead zirconate titanate (PZT), single crystal lead magnesium niobate-lead titanate (PMN-PT), aluminum nitride (AlN), scandium (Sc) doped AlN, or any combination thereof, and wherein the implantable neurostimulator device has a length in a range of 5 mm to 20 mm and a diameter in a range of 1 mm to 5 mm. In some non-limiting embodiments, the at least one transducer device comprises a plurality of transducer elements, wherein each transducer element of the plurality of transducer elements includes PZT, polyvinylidene fluoride, polyvinylidene difluoride (PVDF), or any combination thereof. In some non-limiting embodiments, the plurality of transducer elements are formed in a plurality of rows, wherein the plurality of rows are spaced equidistant around a perimeter of the at least one transducer device. In some non-limiting embodiments, the at least one transducer device comprises the pMUT array, wherein the pMUT array includes PZT and AlN. In some non-limiting embodiments, the at least one transducer device is operated independent of an onboard processor. In some non-limiting embodiments, the implantable neurostimulator device includes an enclosure, wherein the enclosure has a cylindrical design with a plurality of internal surfaces, and wherein the at least one transducer device comprises a plurality of elements of the pMUT array that are positioned on the plurality of internal surfaces of the enclosure. In some non-limiting embodiments, the plurality of elements of the pMUT array comprises a plurality of thin film elements deposited on the plurality of internal surfaces of the enclosure. In some non-limiting embodiments, the at least one transducer device is configured to receive an acoustic signal from an energy delivery device and convert the acoustic signal to an electrical signal to provide an action potential to activate a nerve. In some non-limiting embodiments, the implantable neurostimulator device includes an electrode device, wherein the electrode device is configured to receive the electrical signal and apply the electrical signal to an environment inside a body of a patient. In some non-limiting embodiments, the implantable neurostimulator device includes a rectification circuit, wherein the rectification circuit is configured to covert an output of the at least one transducer to a DC electrical pulse to provide electrical stimulation to an environment inside a body of a patient. In some non-limiting embodiments, the at least one transducer device includes a plurality of transducer elements, and the implantable neurostimulator device includes a core structure, wherein the core structure is sized and configured to hold the plurality of transducer elements.
In some non-limiting embodiments, a system for providing neurostimulation to a target location of a body of a user, includes an implantable neurostimulator device comprising at least one transducer device that includes a gas matrix piezoelectric (GMP) array, or a piezoelectric micromachined ultrasound transducer (pMUT) array, wherein the at least one transducer device comprises a material, wherein the material includes lead zirconate titanate (PZT), single crystal lead magnesium niobate-lead titanate (PMN-PT), aluminum nitride (AlN), scandium (Sc) doped AlN, or any combination thereof, and wherein the implantable neurostimulator device has a length in a range of 5 mm to 20 mm and a diameter in a range of 1 mm to 5 mm. In some non-limiting embodiments, the system includes an energy delivery device that includes at least one second transducer device, wherein the at least one second transducer device comprises a material, and wherein the material includes PZT, PVDF, AlN, scandium (Sc) doped AlN, any combination thereof. In some non-limiting embodiments, the at least one second transducer device includes a GMP array, a polymer matrix piezocomposite array, a capacitive micro-machined acoustic transducer (cMUT) array, or a piezoelectric micromachined ultrasound transducer (pMUT) array. In some non-limiting embodiments, the energy delivery device includes at least one beam-forming processor configured to cause the at least one second transducer device to produce an acoustic wave, wherein the implantable neurostimulator device is configured to receive the acoustic wave from the energy delivery device, covert the acoustic wave to an electrical energy signal, and apply the electrical energy signal to an environment inside a body of a patient. In some non-limiting embodiments, the acoustic wave comprises a plurality of pulses having a pulse repetition frequency, wherein a pulse width of each pulse of the plurality of pulses is in a range of 10 ns to 10 μs, and wherein the pulse repetition frequency is in a range of 1 Hz to 50 Hz.
In this way, embodiments of the present disclosure provides an implantable neurostimulator device and a system for providing neurostimulation to a target location of a body of a user that allows for providing power and/or control signals to the implantable medical device that is positioned inside the body of the patient. Further, embodiments of the present disclosure provide an implantable medical device that allows for accurate and configurable operation to provide neurostimulation to a target location that also has a form factor that allows for implantation in any location inside the body of the patient.
1 FIG. 1 FIG. 1 FIG. 100 100 102 104 106 108 104 106 Referring now to,is a diagram of an example environmentin which devices, systems, methods, and/or products described herein may be implemented. As shown in, environmentincludes implantable neurostimulator device, energy delivery device, user device, and communication network. In some non-limiting embodiments, energy delivery deviceand user devicemay interconnect (e.g., establish a connection to communicate, establish a communication connection, etc.) via wired connections, wireless connections, or a combination of wired and wireless connections.
102 102 102 102 Implantable neurostimulator devicemay include one or more devices configured to receive an acoustic signal from an energy delivery device, convert the acoustic signal to an electrical signal to provide an action potential to activate a nerve, and/or apply the electrical signal to an environment inside a body of a user. Implantable neurostimulator devicemay have a form factor that allows for implantation inside a body of a user. For example, implantable neurostimulator devicemay be sized and configured to be implantable at a specific location inside the body of a user. In some non-limiting embodiments, implantable neurostimulator devicemay have a length in a range of 5 mm to 20 mm and a width (e.g., a diameter) in a range of 1 mm to 5 mm.
104 102 104 104 104 104 104 104 104 104 Energy delivery devicemay include one or more devices configured to provide power, in the form of acoustic waves (e.g., ultrasonic waves, ultrasonic beams, etc.), that is to be received by implantable neurostimulator device(e.g., that is implanted inside a body of a user). For example, energy delivery devicemay include appropriate electrical circuit components, such as a transducer and a processor to control the transducer. In some non-limiting embodiments, energy delivery devicemay be sized and configured to be wearable on the body of the user. For example, energy delivery devicemay have a wearable form-factor that allows for energy delivery deviceto be placed upon and/or adhered to a body of a patient (e.g., a torso of a patient) for a period of time. In some non-limiting embodiments, energy delivery devicemay have the following dimensions, including a length in a range of 60 to 250 mm, a width in a range of 40 to 250 mm, and a height in a range of 15 to 50 mm. In one example, energy delivery devicemay have the following dimensions a length of 75 mm, a width of 55 mm, and a height of 19 mm. In some non-limiting embodiments, energy delivery devicemay include a power source that is carried on board. For example, energy delivery devicemay include a battery having a capacity in a range of 50 to 900,000 mAh.
104 104 104 In some non-limiting embodiments, energy delivery devicemay include a 32-channel phased transducer array, which may be capable of providing an equivalent of 128-channel beam forming capability for high resolution focusing by mirroring the phased transducer array design on two different axes. In such an example, energy delivery devicemay provide a peak frequency at 400 kHz and channel spacing at 1.5 mm, which may be equivalent to less than half of an ultrasonic wavelength in water and provides the ability to steer and focus an acoustic wave by avoiding energy loss due to side lobe generation. In some non-limiting embodiments, energy delivery devicemay include circuitry and a transducer device capable of steering and focusing an acoustic wave with center focus conditions with target depths between 1 and 500 mm, steering conditions with target depths between 1 and 500 mm, and steering angles between 0 and 90 degrees in a volumetric space.
104 102 104 102 104 102 104 102 104 104 102 104 In some non-limiting embodiments, energy delivery devicemay provide power (e.g., as an acoustic signal) to implantable neurostimulator devicebased on a transducer of energy delivery devicethat has channel control. In some non-limiting embodiments, implantable neurostimulator devicemay be powered by a 2-dimensional phased array ultrasonic transducer with 32-channel control of energy delivery device. In some non-limiting embodiments, implantable neurostimulator devicemay be powered by a 2-dimensional phased array ultrasonic transducer with 128-channel control of energy delivery device. In some non-limiting embodiments, implantable neurostimulator devicemay be powered by a 2-dimensional phased array ultrasonic transducer with 256 ultrasonic piezoelectric elements of energy delivery device. In this way, energy delivery devicemay control individual transducer elements of a transducer device of Implantable neurostimulator device. Further details regarding embodiments of energy delivery devicemay be found in International Patent Application No. PCT/US2021/030464 filed on May 3, 2021, which is incorporated by reference herein in its entirety.
106 104 108 106 106 104 106 102 104 106 104 User devicemay include one or more devices configured to be in communication with energy delivery devicevia communication network. For example, user devicemay include a desktop computer (e.g., a client device that communicates with a server), a mobile computer (e.g., a mobile device, such as a smartphone, a tablet, etc.), and/or the like. User devicemay be configured to transmit data to and/or receive data from energy delivery devicevia a short-range wireless communication connection (e.g., a near-field communication (NFC) connection, a radio frequency identification (RFID) communication connection, a Bluetooth® communication connection, and/or the like). In some non-limiting embodiments or aspects, user devicemay be associated with a user or an individual (e.g., a medical practitioner) administering a treatment with implantable neurostimulator deviceand energy delivery device. In some non-limiting embodiments, user devicemay include an interface (e.g., a graphical user interface (GUI)) that allows for selection of operational features for control (e.g., only control) of energy delivery devicebased on an application (e.g., a computer application, a mobile application, etc.).
108 108 Communication networkmay include one or more wired and/or wireless networks. For example, communication networkmay include a cellular network (e.g., a long-term evolution (LTE) network, a third generation (3G) network, a fourth generation (4G) network, a code division multiple access (CDMA) network, etc.), a public land mobile network (PLMN), a local area network (LAN), a wide area network (WAN), a metropolitan area network (MAN), a telephone network (e.g., the public switched telephone network (PSTN)), a private network, an ad hoc network, an intranet, the Internet, a fiber optic-based network, a cloud computing network, and/or the like, and/or a combination of some or all of these or other types of networks.
1 FIG. 1 FIG. 1 FIG. 1 FIG. 100 100 The number and arrangement of devices shown inare provided as an example. There may be additional devices, fewer devices, different devices, or differently arranged devices than those shown in. Furthermore, two or more devices shown inmay be implemented within a single device, or a single device shown inmay be implemented as multiple devices. Additionally or alternatively, a set of devices of environmentmay perform one or more functions described as being performed by another set of devices of environment.
2 FIG. 2 FIG. 2 FIG. 200 200 102 104 106 102 104 106 200 200 200 202 204 206 208 210 212 214 200 504 506 Referring now to,is a diagram of example components of device. Devicemay correspond to implantable neurostimulator device, energy delivery device, and/or user device. In some non-limiting embodiments or aspects, implantable neurostimulator device, energy delivery device, and/or user devicemay include at least one deviceand/or at least one component of device. As shown in, devicemay include bus, processor, memory, storage component, input component, output component, and communication interface. Additionally or alternatively, devicemay correspond to other devices disclosed herein, including power control moduleand/or power source.
202 200 204 204 206 204 204 Busmay include a component that permits communication among the components of device. In some non-limiting embodiments or aspects, processormay be implemented in hardware or a combination of hardware and software. For example, processormay include a processor (e.g., a central processing unit (CPU), a graphics processing unit (GPU), an accelerated processing unit (APU), etc.), a microprocessor, a digital signal processor (DSP), and/or any processing component (e.g., a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), etc.) that can be programmed to perform a function. Memorymay include random access memory (RAM), read-only memory (ROM), and/or another type of dynamic or static storage device (e.g., flash memory, magnetic memory, optical memory, etc.) that stores information and/or instructions for use by processor. In some non-limiting embodiments, processormay include a beam forming microprocessor as described herein.
208 200 208 Storage componentmay store information and/or software related to the operation and use of device. For example, storage componentmay include a hard disk (e.g., a magnetic disk, an optical disk, a magneto-optic disk, a solid state disk, etc.), a compact disc (CD), a digital versatile disc (DVD), a floppy disk, a cartridge, a magnetic tape, and/or another type of computer-readable medium, along with a corresponding drive.
210 200 210 212 200 Input componentmay include a component that permits deviceto receive information, such as via user input (e.g., a touchscreen display, a keyboard, a keypad, a mouse, a button, a switch, a microphone, a camera, etc.). Additionally or alternatively, input componentmay include a sensor for sensing information (e.g., a global positioning system (GPS) component, an accelerometer, a gyroscope, an actuator, etc.). Output componentmay include a component that provides output information from device(e.g., a display, a speaker, one or more light-emitting diodes (LEDs), etc.).
214 200 214 200 214 Communication interfacemay include a transceiver-like component (e.g., a transceiver, a separate receiver and transmitter, etc.) that enables deviceto communicate with other devices, such as via a wired connection, a wireless connection, or a combination of wired and wireless connections. Communication interfacemay permit deviceto receive information from another device and/or provide information to another device. For example, communication interfacemay include an Ethernet interface, an optical interface, a coaxial interface, an infrared interface, a radio frequency (RF) interface, a universal serial bus (USB) interface, a Wi-Fi® interface, a Bluetooth® interface, a Zigbee® interface, a cellular network interface, and/or the like.
200 200 204 206 208 Devicemay perform one or more processes described herein. Devicemay perform these processes based on processorexecuting software instructions stored by a computer-readable medium, such as memoryand/or storage component. A computer-readable medium (e.g., a non-transitory computer-readable medium) is defined herein as a non-transitory memory device. A non-transitory memory device includes memory space located inside of a single physical storage device or memory space spread across multiple physical storage devices.
206 208 214 206 208 204 Software instructions may be read into memoryand/or storage componentfrom another computer-readable medium or from another device via communication interface. When executed, software instructions stored in memoryand/or storage componentmay cause processorto perform one or more processes described herein. Additionally or alternatively, hardwired circuitry may be used in place of or in combination with software instructions to perform one or more processes described herein. Thus, embodiments or aspects described herein are not limited to any specific combination of hardware circuitry and software.
206 208 200 206 208 Memoryand/or storage componentmay include data storage or one or more data structures (e.g., a database and/or the like). Devicemay be capable of receiving information from, storing information in, communicating information to, or searching information stored in the data storage or one or more data structures in memoryand/or storage component. For example, the information may include input data, output data, transaction data, account data, or any combination thereof.
2 FIG. 2 FIG. 200 200 200 The number and arrangement of components shown inare provided as an example. In some non-limiting embodiments or aspects, devicemay include additional components, fewer components, different components, or differently arranged components than those shown in. Additionally or alternatively, a set of components (e.g., one or more components) of devicemay perform one or more functions described as being performed by another set of components of device.
3 FIG. 3 FIG. 3 FIG. 102 102 302 304 306 102 Referring now to,is a diagram of implantable neurostimulator device. As shown in, implantable neurostimulator devicemay include receiver device, rectification circuit, and electrode device. In some non-limiting embodiments, implantable neurostimulator devicemay be covered (e.g., encapsulated) with a biocompatible material, such as alumina and/or a material including alumina.
302 302 In some non-limiting embodiments, receiver devicemay include one or more devices that are configured to receive an acoustic signal (e.g., an acoustic wave, a plurality of acoustic waves, etc.) and convert the acoustic signal to an electrical signal (e.g., an electrical current) to provide an action potential to activate a nerve. For example, receiver devicemay include one or more transducer devices.
402 104 402 104 In some non-limiting embodiments, the transducer device may include a transducer array, where the transducer array includes a plurality of transducer elements (e.g., individual transducer elements). In some non-limiting embodiments, the plurality of transducer elements may be connected with one or more electrodes on a first side and one or more electrodes on a second side (e.g., a side opposite the first side). In some non-limiting embodiments, the plurality of transducer elements may be controlled with signal channels individually (e.g., each transducer element controlled with one signal channel) or as a plurality (e.g., a set of transducer elements controlled with one signal channel). In one example, a first set of transducer elements of the transducer array may be controlled by a first processor (e.g., a first beam forming microprocessor, such as beam forming microprocessorof energy delivery device), and a second set of transducer elements of the transducer array may be controlled by a second processor (e.g., a second beam forming microprocessor, such as another beam forming microprocessorof energy delivery device).
In some non-limiting embodiments, the transducer device may be made (e.g., constructed, fabricated, etc.) from a material that may include lead zirconate titanate (PZT), polyvinylidene difluoride (PVDF), aluminum nitride (AlN), scandium (Sc) doped AlN, or a combination of these materials. In some non-limiting embodiments, the transducer device may include a gas matrix piezoelectric (GMP) array, a capacitive micro-machined acoustic transducer (cMUT) array, and/or a piezoelectric micro-machined ultrasound transducer (pMUT) array. In some non-limiting embodiments, the transducer device may include a microelectronic mechanical systems (MEMS) transducer device.
302 302 302 302 302 302 302 302 302 302 302 In some non-limiting embodiments, receiver device(e.g., a transducer device of receiver device) may be operated independent of an onboard processor (e.g., a processor is not included onboard receiver device). For example, receiver devicemay be constructed without a processor (e.g., a controller, such as a microcontroller) for controlling operations of receiver device. In this way, receiver devicemay be a passive electronic component that receives an acoustic signal and the construction of receiver devicemay determine how receiver deviceoperates to produce an electrical signal. In some non-limiting embodiments, receiver devicemay be operated with a processor. For example, individual elements of receiver device(e.g., individual elements of a transducer device of receiver device) may be operated based on control signals provided by a processor.
304 304 304 304 302 302 In some non-limiting embodiments, rectification circuitmay include one or more devices for converting an alternating current (AC) electrical signal into a direct current (DC) electrical signal. For example, rectification circuitmay include one or diodes (e.g., one or more P-N junction diodes). In some non-limiting embodiments, rectification circuitmay convert an AC electrical signal into DC pulse for stimulation. In some non-limiting embodiments, rectification circuitmay be configured to covert an output of receiver device(e.g., one or more transducer devices of receiver device) to a DC electrical pulse to provide electrical stimulation to an environment inside a body of a patient.
304 306 304 304 In some non-limiting embodiments, rectification circuitmay produce an output of up to 10 V and 10 mA (e.g., when electrode deviceis exposed to resistance of 1 k-ohm). In some non-limiting embodiments, rectification circuitmay be configured for rectification of individual transducer elements for lower destructive interference during summation of transducer element channels. In some non-limiting embodiments, rectification circuitmay include an application specific integrated circuit (ASIC) to perform a method of signal rectification and/or transformation, which may include channel multiplexing, for single or multi-channel nerve activation (e.g., based on operation of individual transducer elements).
306 306 306 304 306 302 302 306 306 306 306 302 In some non-limiting embodiments, electrode devicemay include one or more devices for providing a conducting surface to apply an electrical signal (e.g., an AC electrical signal or a DC electrical signal) to a body of a user. For example, electrode devicemay include one or more electrodes, one or more electrode components, one or more electrical leads, and/or the like. In some non-limiting embodiments, electrode devicemay be configured to receive an electrical signal (e.g., an electrical signal from rectification circuit) and apply the electrical signal to an environment inside a body of a patient. In some non-limiting embodiments, electrode devicemay be connected to (e.g., electrically connected to) receiver device(e.g., a transducer device of receiver device). In some non-limiting embodiments, electrode devicemay include a conductive material, such as a metal. For example, electrode devicemay be constructed of a conductive material formed in an appropriate shape. In some non-limiting embodiments, electrode devicemay include one or more leads that are configured to provide stimulation to a location (e.g., a location of a nerve or neuron) of a body of a user. In some non-limiting embodiments, the lead may include an insulated wire of an appropriate size. In some non-limiting embodiments, electrode devicemay be formed integrally with receiver device.
4 FIG. 4 FIG. 4 FIG. 104 104 402 404 402 404 402 404 202 Referring now to,is a diagram of energy delivery device. As shown in, energy delivery devicemay include beam forming microprocessorand transducer device. In some non-limiting embodiments, beam forming microprocessorand transducer devicemay interconnect (e.g., establish a connection to communicate, establish a communication connection, etc.) via wired connections, wireless connections, or a combination of wired and wireless connections. In some non-limiting embodiments, beam forming microprocessorand transducer devicemay be connected via a bus (e.g., bus).
402 404 402 404 404 402 404 In some non-limiting embodiments, beam forming microprocessormay include one or more devices that are configured to control transducer device. For example, beam forming microprocessormay include a microprocessor that is configured to provide high-voltage, high-frequency electrical signals to transducer deviceand transducer devicemay convert the high-voltage, high-frequency electrical signals into an output, where the output may include an acoustic wave. In some non-limiting embodiments, beam forming microprocessormay include a phase delay feature that allows for steering and focusing of acoustic waves produced by transducer device.
402 402 402 402 402 In some non-limiting embodiments, beam forming microprocessormay include the following specifications: a channel count from 1 to 32,768; electrical current limit per channel from 0.001 to 5 A; zero to peak voltage from 5 to 500V; peak-to-peak voltage from 10 to 1000V; and/or zero to peak negative from −5to −500 V. In some non-limiting embodiments, beam forming microprocessormay include an application specific integrated circuit (ASIC). In some non-limiting embodiments, beam forming microprocessormay have the following dimensions: a length in a range of 50-70 mm; a width in a range of 30-70 mm; and a height in a range of 1-20 mm. In some non-limiting embodiments, beam forming microprocessormay include the following output specifications: voltage signal outputs in a range of 1 to 1,000V peak to peak; a clock frequency up to 500 MHz; and memory to store information, such as waveforms and algorithms (e.g., phasing algorithms for individual transducer device channel control to allow focusing and/or steering of an acoustic wave produced by the transducer device). In some non-limiting embodiments, beam forming microprocessormay include the following input specifications: an interface (e.g., Bluetooth® interface) for receiving signals; on board programming; control of one or more channels; control of one or more channel delays; delay resolution in a range of 1 ns to 500 μs; and a plurality of input/output (I/O) pins for processing various information, including trigger conditions.
404 404 404 In some non-limiting embodiments, transducer devicemay include one or more devices that are configured to produce an acoustic wave. For example, transducer devicemay include a transducer that is configured to produce an acoustic wave (e.g., an ultrasonic beam, an ultrasonic wave, etc.) having specific parameters. In some non-limiting embodiments, transducer devicemay include a transducer that can be used to send and receive signals (e.g., pulse-echo) and/or receive signals transmitted by an energy delivery transducer or another transducer (e.g., pitch-catch).
404 404 404 404 404 404 In some non-limiting embodiments, transducer devicemay include an energy delivery transducer. For example, transducer devicemay include an energy delivery transducer that is configured to provide an acoustic wave that may be configured to provide therapy to a patient, which may be used as a detection signal for steering a beam path of the acoustic wave, and/or the like. In some non-limiting embodiments, transducer devicemay include a detection transducer (e.g., an imaging transducer). For example, transducer devicemay include a detection transducer that is configured to receive an acoustic wave that is a reflection of an acoustic wave provided by transducer deviceand provide data associated with the reflection of an acoustic wave. In some non-limiting embodiments, transducer devicemay be configured to provide data associated with an image (e.g., an ultrasound image) of an object based on the reflection of an acoustic wave.
404 402 402 In some non-limiting embodiments, transducer devicemay include a transducer array, where the transducer array include includes a plurality of transducer elements (e.g., individual transducer elements). In some non-limiting embodiments, the plurality of transducer elements may be connected with one or more ground plane electrodes on a first side and a signal channel connection on a second side (e.g., a side opposite the first side). In some non-limiting embodiments, the plurality of transducer elements may be controlled with signal channels individually (e.g., each transducer element controlled with one signal channel) or as a plurality (e.g., a set of transducer elements controlled with one signal channel). In one example, a first beam forming microprocessor (e.g., one beam forming microprocessor) may control a first set of transducer elements of a transducer array and a second beam forming microprocessor (e.g., one beam forming microprocessor) may control a second set of transducer elements of the transducer array.
404 404 404 In some non-limiting embodiments, transducer devicemay be made (e.g., constructed, fabricated, etc.) from a material that may include lead zirconate titanate (PZT), polyvinylidene difluoride (PVDF), aluminum nitride (AlN), scandium (Sc) doped AlN, or a combination of these materials. In some non-limiting embodiments, transducer devicemay include a gas matrix piezoelectric (GMP) array, a capacitive micro-machined acoustic transducer (cMUT) array and/or a piezoelectric micro-machined ultrasound transducer (pMUT) array. In some non-limiting embodiments, transducer devicemay include a microelectronic mechanical systems (MEMS) transducer device.
404 402 404 104 In some non-limiting embodiments, transducer devicemay be electrically connected to beam forming microprocessorusing a balls grid array (BGA), by being directly bonded via a flip chip, a through-silicon via (TSV), using a push/pull connector, using direct soldering, using wire-bond interconnects, and/or the like. In some non-limiting embodiments, transducer devicemay be made (e.g., formed, constructed, fabricated, etc.) onto a flexible substrate, such as a flexible printed circuit board (PCB) and/or a flexible electrode, to allow for conformance of energy delivery deviceto a body of a user.
5 FIG. 5 FIG. 5 FIG. 500 500 502 504 506 508 502 102 504 104 Referring now to,is a diagram of systemfor providing neurostimulation to a target location of a body of a user (e.g., a patient, a recipient of treatment, etc.). As shown in, systemmay include implantable neurostimulator device, energy delivery device, power control module, and power source. In some non-limiting embodiments, implantable neurostimulator devicemay be the same as or similar to implantable neurostimulator device. In some non-limiting embodiments, energy delivery devicemay be the same as or similar to energy delivery device.
502 504 504 In some non-limiting embodiments, implantable neurostimulator deviceis sized and configured to be implanted inside a body of a user and configured to receive an acoustic signal generated by energy delivery device. In some non-limiting embodiments, energy delivery deviceis configured to be applied to an external surface (e.g., on the skin) of the body and to provide the acoustic signal according to predetermined parameters.
504 504 504 504 504 504 a a a In some non-limiting embodiments, energy delivery devicemay include coupling padfor coupling (e.g., acoustically coupling) energy delivery deviceto the body of the user. In some non-limiting embodiments, coupling padmay include a material for coupling energy delivery deviceto a body of a user. For example, coupling padmay include an adhesive, such as a biocompatible adhesive.
504 504 504 504 504 a a a In some examples, coupling padmay include a solid coupling material or semi-solid coupling material. The semi-solid coupling material may include a hydrogel having an internal water content that is greater than 20%. In some non-limiting embodiments, the material for coupling may include an adhesive, a liquid-based acoustic coupling gel, and/or the like. In some non-limiting embodiments, coupling padmay be disposable. In some non-limiting embodiments, coupling padmay include a hydrogel material that provides acoustic coupling of energy delivery deviceto acoustically match energy delivery deviceto the skin of the user during operation.
506 506 506 506 506 504 In some non-limiting embodiments, power sourcemay include a device which receives and converts standard electrical power inputs. For example, power sourcemay include a power adapter which can accommodate standard electrical power inputs (e.g., a power signal in a range between 100-240V and having a frequency in a range between 50-60 Hz) and provide an amount of power in a range from 5 to 500 W. Power sourcemay include a plug that is configured to be plugged into a standard wall outlet. In some non-limiting embodiments, power sourcemay be configured to convert an AC power signal (e.g., an AC voltage) to a DC power signal (e.g., a DC voltage). In some non-limiting embodiments, power control modulemay include electronic circuitry that is configured to provide power conditioning for a power signal that is provided by energy delivery device.
6 6 FIGS.A-G 6 6 FIGS.A-G 6 6 FIGS.A-G 600 600 602 604 606 608 610 612 600 102 502 606 608 306 612 304 Referring now to,are diagrams of a non-limiting embodiment of implantable neurostimulator device. As shown in, implantable neurostimulator devicemay include transducer device, core structure, first electrode component, second electrode component, enclosure, and rectification circuit. In some non-limiting embodiments, implantable neurostimulator devicemay be the same as or similar to implantable neurostimulator deviceand/or implantable neurostimulator device. In some non-limiting embodiments, first electrode componentand/or second electrode componentmay be the same as or similar to electrode device. In some non-limiting embodiments, rectification circuitmay be the same as or similar to rectification circuit.
606 602 602 604 604 608 608 610 612 610 612 610 612 612 606 606 604 610 610 610 6 FIG.B 6 FIG.C 6 FIG.C 6 FIG.B In some non-limiting embodiments, first electrode componentmay be sized and configured to be positioned within transducer device, transducer deviceis sized and configured to be positioned within core structure. As shown in, core structuremay be sized and configured to be positioned within second electrode component, and second electrode componentis sized and configured to be positioned within enclosure. As shown in, rectification circuitmay be positioned at an end of enclosure. As further shown in, rectification circuitmay be sized and configured to be positioned within an open end of enclosure. In some non-limiting embodiments, rectification circuitmay be positioned so that rectification circuitis electrically connected to first electrode component(e.g., an end of first electrode componentthat protrudes from core structure, as shown in). In some non-limiting embodiments, enclosuremay be constructed of an appropriate material, such as a biocompatible material. The biocompatible material may include titanium. In some non-limiting embodiments, enclosuremay have a cylindrical design. For example, enclosuremay have a square cylindrical design, a hexagonal cylindrical design, an octagonal cylindrical design, and/or the like.
6 FIG.D 604 604 610 604 610 604 610 As shown in, core structuremay have a cylindrical design. In some non-limiting embodiments, core structuremay have a cylindrical design that corresponds to enclosure. For example, core structuremay have a cylindrical design that matches a shape of enclosureand allows core structureto be positioned within enclosure.
6 FIG.D 604 604 604 604 606 604 604 b a b As further shown in, core structuremay include center apertureand/or a plurality of apertures. In some non-limiting embodiments, center aperturemay be sized and configured to receive first electrode component. In some non-limiting embodiments, core structuremay be constructed based on a molding process, a mechanical process (e.g., a subtractive manufacturing process), and/or an additive manufacturing process, such as 3D printing. In some non-limiting embodiments, core structuremay be constructed of an appropriate material, such as a ceramic material or a partially ceramic material.
604 602 604 604 604 604 604 604 604 604 602 604 604 604 604 604 604 a c a c c c a c a c In some non-limiting embodiments core structureis sized and configured to hold the plurality of transducer elements. In some non-limiting embodiments, a plurality of aperturesmay be arranged in rows. For example, the plurality of aperturesmay be aligned in a straight line (e.g., extending from one end of core structureto another end of core structurein a straight line) to form one row. In some non-limiting embodiments, core structuremay include a plurality of rowsthat correspond to a number of transducer elements of transducer device. In some non-limiting embodiments, the plurality of rowsmay be spaced equidistant around a perimeter (e.g., around a circumference) of core structure. In some non-limiting embodiments, the plurality of aperturesarranged in rowmay be spaced apart. For example, the plurality of aperturesarranged in rowmay be spaced equidistantly apart.
604 604 604 610 604 610 604 610 604 608 604 608 604 608 a a In some non-limiting embodiments, each apertureof a plurality of aperturesmay be sized and configured to receive a transducer element. In some non-limiting embodiments, a length of core structuremay be less than a length of enclosureand/or a width (e.g., a diameter) of core structuremay be less than a width (e.g., a diameter) of enclosure. In this way, core structuremay be sized and configured to be positioned within enclosure. In some non-limiting embodiments, a length of core structuremay be less than or equal to a length of second electrode componentand/or a width (e.g., a diameter) of core structuremay be less than or equal to a width (e.g., a diameter) of second electrode component. In this way, core structuremay be sized and configured to be positioned within second electrode component.
6 FIG.E 6 FIG.E 602 602 602 602 606 602 602 602 604 602 602 602 602 602 602 602 602 602 602 602 602 b a b b b a c a c c a c a c As shown in, transducer devicemay include center apertureand an array of transducer elements. As further shown in, center aperturemay be sized and configured to receive first electrode component. In some non-limiting embodiments, center apertureof transducer deviceis configured to be concentric with center apertureof core structure. In some non-limiting embodiments, a plurality of transducer elementsmay be arranged in a plurality of rows. For example, the plurality of transducer elementsmay be aligned in a straight line (e.g., extending from one end of transducer deviceto another end of transducer devicein a straight line) to form one row. In some non-limiting embodiments, the plurality of rowsare spaced equidistant around a perimeter (e.g., around a circumference) of transducer device. In some non-limiting embodiments, the plurality of transducer elementsarranged in rowmay be spaced apart. For example, the plurality of transducer elementsarranged in rowmay be spaced equidistantly apart.
6 FIG.E 602 602 602 602 602 606 602 602 608 a aa ab aa a ab a As further shown in, each transducer elementmay include first endand second end. In some non-limiting embodiments, first endof transducer elementmay be sized and configured to contact (e.g., to be electrically connected and form a conductive path) first electrode component. In some non-limiting embodiments, second endof transducer elementmay be sized and configured to contact (e.g., to be electrically connected and form a conductive path) second electrode component.
6 FIG.E 602 602 602 602 602 602 602 602 602 602 602 600 a c a ab a b c a As further shown in, transducer devicemay include a transducer array of transducer elements, with six rowsof nine transducer elements, with a total of fifty four transducer elements. In some non-limiting embodiments, first endsof transducer elementsextend annularly outward from a center (e.g., a center defined by center aperture) of transducer device. In some non-limiting embodiments, the number of rowsand the number of transducer elementsmay be more or less than six and fifty four, respectively, depending on the application for transduceror implantable neurostimulator device.
6 6 FIGS.F andG 6 6 FIGS.F andG 6 6 FIGS.F andG 614 602 604 606 602 604 606 602 604 604 602 604 604 602 606 606 604 606 602 604 a a a a As shown in, transducer assemblymay include transducer device, core structure, and first electrode componentassembled together. As further shown in, transducer devicemay be positioned within core structureand first electrode componentmay be positioned within a center aperture of transducer deviceand a center aperture of core structure. In some non-limiting embodiments, core structureis sized and configured to hold the plurality of transducer elements. For example, core structuremay have a lattice structure with a plurality of aperturesthat are sized and configured to receive the plurality of transducer elements. As further shown in, first endof first electrode componentmay protrude from core structurewhen first electrode componentis positioned within a center aperture of transducer deviceand a center aperture of core structure.
6 FIG.F 6 FIG.F 6 FIG.G 602 602 604 604 602 602 602 604 604 604 602 602 604 602 602 606 602 602 604 608 606 602 608 602 602 608 606 604 a a c a c a ab a aa a ab a a ab a As further shown in, a plurality of transducer elementsof transducer devicemay be positioned in a plurality of corresponding aperturesof core structure. In some non-limiting embodiments, one or more rowsof transducer elementsof transducer devicemay align with one or more rowsof aperturesof core structure. As further shown in, second endof transducer elementsmay protrude above a surface (e.g., an external surface) of core structure. As shown in, first endof transducer elementsmay be in contact with first electrode component. In some non-limiting embodiments, second endof transducer elementsmay protrude above a surface (e.g., an external surface) of core structureand contact second electrode component. In this way, an electrical path (e.g., a current path) is formed via first electrode component, transducer elements, and second electrode component. Further, in this way, second endof transducer elementsmay contact second electrode componentwithout second electrode componentbeing in contact with core structure.
6 FIG.F 604 604 602 604 602 604 602 602 602 604 602 602 504 602 c a c c c a c c As further shown in, core structuremay include one or more sectionsthat are not designed to receive an acoustic signal, since there are no transducer elementsin section. In some non-limiting embodiments, transducer devicemay be designed to reduce the surface area of sections. For example, transducer devicemay include a number of rowsof transducer elementsthat reduce the surface area of sections, such as six or more (e.g., eight, ten, twelve, etc.) rows. In this way, transducer devicemay be designed to effectively receive an acoustic signal (e.g., from energy delivery device) despite the orientation of transducer devicein a body of a user.
6 FIG.G 6 FIG.G 602 602 602 602 602 608 608 610 a a aa ab a As further shown in, a length of transducer element(e.g., a length of transducer elementas measured from first endand second end) may be 1.53 mm. In some non-limiting embodiments, a length of transducer elementmay be in a range of 0.5 mm to 5 mm. As further shown in, a diameter of second electrode componentmay be 5 mm. In some non-limiting embodiments, a diameter of second electrode componentmay be in a range of 3 mm to 6 mm. In some non-limiting embodiments, a diameter of enclosuremay be in a range of 4 mm to 8 mm.
7 FIG. 7 FIG. 7 FIG. 700 700 702 702 710 700 600 502 102 702 602 302 710 610 a Referring now to,is a diagram of implantable neurostimulator device. As shown in, implantable neurostimulator devicemay include transducer device, which includes transducer elementsand enclosure. In some non-limiting embodiments, implantable neurostimulator devicemay be the same as or similar to implantable neurostimulator device, implantable neurostimulator device, and/or implantable neurostimulator device. In some non-limiting embodiments, transducer devicemay be the same as or similar to transducer deviceand/or receiver device. In some non-limiting embodiments, enclosuremay be the same as or similar to enclosure.
7 FIG. 7 FIG. 700 710 702 702 710 702 710 702 700 702 a a a As shown in, implantable neurostimulator devicemay have an octagonal cylindrical design based on a shape of enclosure. As further shown in, transducer devicemay include a plurality of transducer elementsthat are positioned on each internal surface (e.g., each flat internal surface) of enclosure. In some non-limiting embodiments, one or more transducer elementsmay include a pMUT array constructed from a thin film that is deposited onto an internal surface of enclosure. In some non-limiting embodiments, transducer elementsmay include a piezoelectric micromachined ultrasonic transducer (pMUT) membrane, which is constructed with a thin film of lead zirconate titanate (PZT) and/or aluminum nitride (AlN) deposited onto a circuit (e.g., microchip). In one example, a pMUT membrane may operate in a 3-1 mode, which may allow for a thin and low profile that is well suited for a compact form factor for implantable neurostimulator device. In addition, performance of a pMUT membrane may be more efficient than a standard bulk piezoelectric, which may operate in a 3-3 mode. In another example, an AlN film can also have a higher receive efficiency than PZT, which may provide an advantage for transducer devicewhen used in a receive mode.
702 710 702 700 a a In some non-limiting embodiments, transducer elementsmay be formed with appropriate electrode components (e.g., integral electrode components) so that separate electrode components are not necessary. The use of a pMUT array constructed from a thin film allows for enclosureto have a reduced form factor, while transducer elementsmay have received sensitivity of high bandwidth and/or lower peak frequency, without increasing the thickness of implantable neurostimulator device.
8 FIG. 8 FIG. 8 FIG. 800 800 802 802 808 800 700 600 502 102 802 702 602 302 808 608 a Referring now to,is a diagram of implantable neurostimulator device. As shown in, implantable neurostimulator devicemay include transducer device, which includes transducer elements, and second electrode component. In some non-limiting embodiments, implantable neurostimulator devicemay be the same as or similar to implantable neurostimulator device, implantable neurostimulator device, implantable neurostimulator device, and/or implantable neurostimulator device. In some non-limiting embodiments, transducer devicemay be the same as or similar to transducer device, transducer deviceand/or receiver device. In some non-limiting embodiments, second electrode componentmay be the same as or similar to second electrode component.
808 802 808 808 802 800 a a 8 FIG. In some non-limiting embodiments, electrode componentmay include a flexible circuit (e.g., a flexible printed circuit board) with transducer elementsformed on a surface of electrode componentand electrode componentmay be rolled into a cylindrical design as shown in. In some non-limiting embodiments, transducer elementsmay include diced PZT elements. The design of implantable neurostimulator devicemay allow for a rectification circuit to be mounted directly onto the flexible circuit, as well as a small and compact form factor with a high volume fraction of PZT for greater acoustic signal to electrical signal conversion efficiency.
Although the above embodiments have been described in detail for the purpose of illustration based on what is currently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is solely for that purpose and that the present disclosure is not limited to the described embodiments or aspects but, on the contrary, is intended to cover modifications and equivalent arrangements that are within the spirit and scope of the appended claims. For example, it is to be understood that the present disclosure contemplates that, to the extent possible, one or more features of any embodiment or aspect can be combined with one or more features of any other embodiment or aspect.
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November 3, 2023
June 25, 2026
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